Premier Research is looking for a Project Manager II/Senior Project Manager to join our Oncology team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
Roles and Responsibilities
- Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery.
- Adherence to project budget and scope of work to realize project profitability.
- All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures.
- Project risks identification and mitigation.
- Effective communication, and project status reports and monthly progress reports are provided both internally and externally.
- Compliance for project-related training.
- Adequate resourcing to meet project deliverables and milestones.
- Representation at client meetings along with commercial colleagues to help win new business.
Qualification and Experience
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience.
- 6 years relevant experience, preferably in a CRO/pharmaceutical company/medical device company, including 2 years of clinical project management or clinical management experience.
- 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment.
- Strong budget/finance experience on a project level.
- Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures.
- Able to lead and motivate team members.
- Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively.
- A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools.
- Willingness to travel.